https://doi.org/10.17037/DATA.00002277
The dataset was produced as part of a phase 2 randomised controlled trial of adults with pulmonary tuberculosis, conducted in South Africa (ClinicalTrials.gov, NCT02968927). It consists of 9 data tables from n=199 participants, randomised and who had taken at least one dose of treatment.
Trial investigators and participants are committed to making anonymized patient-level data from this trial available to qualified researchers in a timely manner. Please contact us, including a description of the proposed research and your background, to begin this process.
Dataset on adverse event and serious adverse event report.
| Variable name | Variable type | Display format | Variable description | Response code and description |
| newid | float | %9.0g | Participant study identifier | |
| AE_No | float | %9.0g | AE order by participant | |
| visitid | int | %8.0g | Visit identifier | 10=Day -3; 20=Day 0; 30=Day 1 , 40=Day 7; 50=Day14; 60=Day 21; 70=Day 28; 80=Day 35; 90=Day 42; 100=Day 56; 110=Day84; 120=Day 112, 130=Day 140; 140=Day 180; 150=Unscheduled 1; 160=Unscheduled 2; 170=Unscheduled 3; 180=Unscheduled 4; 190=Unscheduled 5; 200=Unscheduled 6; 210=Unscheduled 7; 220=Day 360; 230=Day 540 |
| aetyp | byte | %28.0g | Type of report | 1 = New report; 2 = Update of an existing report; 3=Resolution |
| aeterm | str71 | %71s | AE term | Free text |
| aeser | byte | %8.0g | Is AE serious? | 0=No; 1=Yes |
| aeserious | byte | %18.0g | AE seriousness | 1=Death; 2 = Life threatening; 3 = Hospitalization; 4 = Disability; 5=Congenital anomaly |
| aeseverity | byte | %51.0g | AE severity | 1 = Mild; 2 = Moderate; 3=Severe (includes life-threating events and death) |
| rifab | byte | %18.0g | AE relationship to rifabutin | 1=Unrelated; 2=Possibly related; 3=Probably related; 4=Definitely related |
| adjuct | byte | %18.0g | AE relationship to the intervention | 1=Unrelated; 2=Possibly related; 3=Probably related; 4=Definitely related |
| aeexp | byte | %10.0g | AE expected or unexpected? | 1=Expected, 2=Unexpected |
| aeaction | byte | %8.0g | AE action taken? | 0=No; 1=Yes |
| sevles | byte | %8.0g | Did the severity of the event lessen? | 0=No; 1=Yes |
| aeles | byte | %8.0g | Did the AE lessen? | AELES |
| sevchng | byte | %18.0g | AE severity change | 1 = Severe to Moderate; 2 = Severe to Mild; 3=Moderate to mild |
| aeoutcome | byte | %41.0g | AE outcome | 1 = Ongoing; 2 = Resolved; 3 = Death; 4=Severity or frequency increased (report as new AE) |
| aetx | byte | %8.0g | Was treatment provided? | 0=No; 1=Yes |
| aemx | byte | %8.0g | Was medication given? | 0=No; 1=Yes |
| aehospital | byte | %8.0g | Was participant hospitalised? | 0=No; 1=Yes |
| aeothtr | byte | %8.0g | Was other treatment required? | 0=No; 1=Yes |
| aesusar | byte | %8.0g | Is the AE classified as a Suspected Unexpected Serious Adverse Reaction (SUSAR)? | 0=No; 1=Yes |
| aetesa | byte | %8.0g | Is the AE classified as a Treatment Emergent Serious AE (TESA)? | 0=No; 1=Yes |
| onsetd | float | %9.0g | Days from randomisation to AE onset | days |
| outcd | float | %9.0g | Days from randomisation to AE outcome | days |
| repd | float | %9.0g | Days from randomisation to AE report | days |
| Variable name | Variable type | Display format | Variable description | Response code and description |
| newid | float | %9.0g | Participant study identifier | |
| visitid | int | %8.0g | Visit identifier | 10=Day -3; 20=Day 0; 30=Day 1 , 40=Day 7; 50=Day14; 60=Day 21; 70=Day 28; 80=Day 35; 90=Day 42; 100=Day 56; 110=Day84; 120=Day 112, 130=Day 140; 140=Day 180; 150=Unscheduled 1; 160=Unscheduled 2; 170=Unscheduled 3; 180=Unscheduled 4; 190=Unscheduled 5; 200=Unscheduled 6; 210=Unscheduled 7; 220=Day 360; 230=Day 540 |
| sex | float | %9.0g | Gender | 1=Male; 2=Female |
| agegrp | byte | %9.0g | Age, grouped | 1=18-24yrs; 2=25-34yrs; 3=35-44yrs; 4= 45-64 yrs |
| country | byte | %12.0g | Country of birth | 1=South Africa; 2= Lesotho; 4= Mozambique; 7=Zimbabwe |
| ethnic | byte | %14.0g | Ethnicity | 1=Black/African; 2=Other |
| marital | byte | %21.0g | Marital status | 1=Single, never married; 2=Married/Cohabitating; 3=other |
| employ | byte | %18.0g | Employment status |
1=Employment full-time; 2 = Employed part-time; 3 = Student/scholar/learner; 4 = Retired/pensioner; 5=Unemployed; 9 = Other, specify |
| ht | float | %9.0g | Height | measured in metres |
| wt | float | %9.0g | Weight | measured in kg |
| bmi | float | %9.0g | Body mass index generated by the system | measured in m/kg2 |
| bmigrp_calc | float | %9.0g | BMI in categories | 1=<18.5; 2=18.5-24.9; 3=25-29.9; 4=30+ |
| Smok_Hist | float | %9.0g | History of smoking | 0=No; 1=Yes |
| diam | byte | %18.0g | Total cavity diameter | 1=0 cm; 2=between 0 and 4 cm; 3=≥4 cm |
| grad | byte | %19.0g | Radiographic extent of disease | 1=minimal; 2 =moderately advanced; 3=far advanced |
| fvc | float | %9.0g | fvc | Litres |
| fev1p | int | %8.0g | fev percentage | Percentage |
| postime_base | float | %9.0g | Time to positivity of liquid culture result (minimum of day -3 and day 0) | in hours |
| CtProbeMin | float | %9.0g | CT probe value minimum for Day -3 Xpert specimen (lowest for all five probes) | |
| CtProbeMea | float | %9.0g | CT probe value mean for Day -3 Xpert specimen (for all five probes) |
NB: Some observations are missing because CRP test was not performed as sample was not taken at visit.
| Variable name | Variable type | Display format | Variable description | Response code and description |
| newid | float | %9.0g | Participant study identifier | |
| visitid | int | %8.0g | Visit identifier | 10=Day -3; 20=Day 0; 30=Day 1 , 40=Day 7; 50=Day14; 60=Day 21; 70=Day 28; 80=Day 35; 90=Day 42; 100=Day 56; 110=Day84; 120=Day 112, 130=Day 140; 140=Day 180; 150=Unscheduled 1; 160=Unscheduled 2; 170=Unscheduled 3; 180=Unscheduled 4; 190=Unscheduled 5; 200=Unscheduled 6; 210=Unscheduled 7; 220=Day 360; 230=Day 540 |
| crp | float | %9.0g | C-Reactive Protein | mg/L |
Note: Some results are missing because: 1. A visit was missed by participant, 2. Sample spoilt due to different reasons, 3 Sample going missing.
| Variable name | Variable type | Display format | Variable description | Response code and description |
| newid | float | %9.0g | Participant study identifier | |
| L7 | str1 | %9s | Liquid culture day 7 | P=Positive, N=Negative, U=Unable to produce, C=Contaminated |
| S7 | str1 | %9s | Solid culture day 7 | P=Positive, N=Negative, U=Unable to produce, C=Contaminated |
| L14 | str1 | %9s | Liquid culture day 14 | P=Positive, N=Negative, U=Unable to produce, C=Contaminated |
| S14 | str1 | %9s | Solid culture day 14 | P=Positive, N=Negative, U=Unable to produce, C=Contaminated |
| L21 | str1 | %9s | Liquid culture day 21 | P=Positive, N=Negative, U=Unable to produce, C=Contaminated |
| S21 | str1 | %9s | Solid culture day 21 | P=Positive, N=Negative, U=Unable to produce, C=Contaminated |
| L28 | str1 | %9s | Liquid culture day 28 | P=Positive, N=Negative, U=Unable to produce, C=Contaminated |
| S28 | str1 | %9s | Solid culture day 28 | P=Positive, N=Negative, U=Unable to produce, C=Contaminated |
| L35 | str1 | %9s | Liquid culture day 35 | P=Positive, N=Negative, U=Unable to produce, C=Contaminated |
| S35 | str1 | %9s | Solid culture day 35 | P=Positive, N=Negative, U=Unable to produce, C=Contaminated |
| L42 | str1 | %9s | Liquid culture day 42 | P=Positive, N=Negative, U=Unable to produce, C=Contaminated |
| S42 | str1 | %9s | Solid culture day 42 | P=Positive, N=Negative, U=Unable to produce, C=Contaminated |
| L56 | str1 | %9s | Liquid culture day 56 | P=Positive, N=Negative, U=Unable to produce, C=Contaminated |
| S56 | str1 | %9s | Solid culture day 56 | P=Positive, N=Negative, U=Unable to produce, C=Contaminated |
| L84 | str1 | %9s | Liquid culture day 84 | P=Positive, N=Negative, U=Unable to produce, C=Contaminated |
| S84 | str1 | %9s | Solid culture day 84 | P=Positive, N=Negative, U=Unable to produce, C=Contaminated |
| L112 | str1 | %9s | Liquid culture day 112 | P=Positive, N=Negative, U=Unable to produce, C=Contaminated |
| S112 | str1 | %9s | Solid culture day 112 | P=Positive, N=Negative, U=Unable to produce, C=Contaminated |
| L140 | str1 | %9s | Liquid culture day 140 | P=Positive, N=Negative, U=Unable to produce, C=Contaminated |
| S140 | str1 | %9s | Solid culture day 140 | P=Positive, N=Negative, U=Unable to produce, C=Contaminated |
| L180 | str1 | %9s | Liquid culture day 180 | P=Positive, N=Negative, U=Unable to produce, C=Contaminated |
| S180 | str1 | %9s | Solid culture day 180 | P=Positive, N=Negative, U=Unable to produce, C=Contaminated |
| L360 | str1 | %9s | Liquid culture day 360 | P=Positive, N=Negative, U=Unable to produce, C=Contaminated |
| S360 | str1 | %9s | Solid culture day 360 | P=Positive, N=Negative, U=Unable to produce, C=Contaminated |
| L540 | str1 | %9s | Liquid culture day 540 | P=Positive, N=Negative, U=Unable to produce, C=Contaminated |
| S540 | str1 | %9s | Solid culture day 540 | P=Positive, N=Negative, U=Unable to produce, C=Contaminated |
| Liquid_Stable | float | %9.0g | Did participant reach liquid culture conversion? | 0=No, 1=Yes |
| Liquid_TimeToStability | int | %10.0g | Time to liquid culture conversion | In days |
| Solid_Stable | float | %9.0g | Did participant reach solid culture conversion? | 0=No, 1=Yes |
| Solid_TimeToStability | int | %10.0g | Time to solid culture conversion | In days |
| Variable name | Variable type | Display format | Variable description | Response code and description |
| newid | float | %9.0g | Participant study identifier | |
| peakSUVbwD1 | double | %14.2f | Peak glycolytic activity on day 1 | |
| maxSUVbwD1 | double | %14.2f | Maximum glycolytic activity on day 1 | |
| totalSUVbwD1 | int | %14.2f | Total glycolytic activity on day 1 | |
| totalmHUD1 | double | %10.0g | Radiodensity on day 1 | |
| peakSUVbwD56 | double | %td | Peak glycolytic activity on day 56 | |
| maxSUVbwD56 | double | %14.2f | Maximum glycolytic activity on day 56 | |
| totalSUVbwD56 | int | %14.2f | Total glycolytic activity on day 56 | |
| totalmHUD56 | double | %14.2f | Radiodensity on day 56 |
| Variable name | Variable type | Display format | Variable description | Response code and description |
| newid | float | %9.0g | Participant study identifier | |
| visitid | int | %8s | Visit identifier | 10=Day -3; 20=Day 0; 30=Day 1 , 40=Day 7; 50=Day14; 60=Day 21; 70=Day 28; 80=Day 35; 90=Day 42; 100=Day 56; 110=Day84; 120=Day 112, 130=Day 140; 140=Day 180; 150=Unscheduled 1; 160=Unscheduled 2; 170=Unscheduled 3; 180=Unscheduled 4; 190=Unscheduled 5; 200=Unscheduled 6; 210=Unscheduled 7; 220=Day 360; 230=Day 540 |
| pft | byte | %8.0g | Was a pulmonary function test done at this visit? | 0=No; 1=Yes |
| pef | float | %9.0g | Peak expiratory flow | Litres/second |
| fvc | float | %9.0g | Forced vital capacity | Litres |
| fev1 | float | %9.0g | Forced expiratory volume in one second | Litres |
| fev1p | int | %8.0g | FEV1 as a percentage of the predicted value | Percentage (%) |
| fev | float | %9.0g | Forced expiratory volume | Litres |
| inter | str24 | %24s | Interpretation | Free text |
| reprod | byte | %8.0g | Are results reproducible? | 0=No; 1=Yes |
| Variable name | Variable type | Display format | Variable description | Response code and description |
| newid | float | %9.0g | Participant study identifier | |
| Arm | byte | %13.0g | Treatment allocation arm | 1=Standard treatment; 2=CC-1105, 3=Everolimus; 4=Auranofin; 5=Ergocalciferol |
| mITT | float | %9s | Modified intentiion to treat population | 0=No; 1=Yes |
| Per_Protocol | float | %9s | Per-protocol population | 0=No; 1=Yes |
| Variable name | Variable type | Display format | Variable description | Response code and description |
| newid | float | %9.0g | Participant study identifier | |
| visitid | int | %8.0g | Visit identifier | 10=Day -3; 20=Day 0; 30=Day 1 , 40=Day 7; 50=Day14; 60=Day 21; 70=Day 28; 80=Day 35; 90=Day 42; 100=Day 56; 110=Day84; 120=Day 112, 130=Day 140; 140=Day 180; 150=Unscheduled 1; 160=Unscheduled 2; 170=Unscheduled 3; 180=Unscheduled 4; 190=Unscheduled 5; 200=Unscheduled 6; 210=Unscheduled 7; 220=Day 360; 230=Day 540 |
| visdays | float | %9.0g | Days from enrolment to visit date | days |
Note: Some results missing because; 1. A visit was missed by a participant, 2. A series of results deemed unreliable were excluded.
| Variable name | Variable type | Display format | Variable description | Response code and description |
| newid | float | %9.0g | Participant study identifier | |
| TotEffd42 | double | %10.0g | Total effect at day 42 | Mtb log CFU |
| MaxEffd42 | double | %10.0g | Maximum effect at day 42 | Mtb log CFU per day |
| TotEffd84 | double | %10.0g | Total effect at day 84 | Mtb log CFU |
| MaxEffd84 | double | %10.0g | Maximum effect at day 84 | Mtb log CFU per day |
| TotEffd140 | double | %10.0g | Total effect at day 140 | Mtb log CFU |
| MaxEffd140 | double | %10.0g | Maximum effect at day 140 | Mtb log CFU per day |