Table 5.
Deaths in the trial
| Treatment group*† | Trial day (post-randomisation) | Trial status | Cause of death | Relationship of adverse event(s) to trial drug‡ |
|---|---|---|---|---|
| DS-TB 4Pa100MZ | Day 482 | Follow-up | Fell down from bulldozer at work | Not related |
| Day 305 | Follow-up | Haematemesis | Not related | |
| Day 39 | On treatment | Fulminant liver failure | Possibly related | |
| Day 436 | Follow-up | Massive haemoptysis | Not related | |
| DS-TB 4Pa200MZ | Day 343 | Follow-up | Sepsis | Not related |
| Day 28 | On treatment | Hepatotoxicity | Possibly related | |
| Day 34 | On treatment | Liver failure with hepatic encephalopathy | Possibly related | |
| DS-TB 6Pa200MZ | Day 163 | Follow-up | Natural causes (unknown) | Unlikely related |
| Day 114 | On treatment | Post-mortem chest X-rays indicated pneumothorax | Not related | |
| Day 469 | Follow-up | Poorly differentiated squamous cell carcinoma of the anal canal | Not related | |
| DS-TB 2HRZE/4HR | Day 576 | Follow-up | Left lobar pneumonia | Not related |
| Day 707 | Follow-up | Lower respiratory tract infection | Not related | |
| MDR-TB 6Pa200MZ | Day 34 | On treatment | Metastatic lung cancer | Not related |
* All participants who received one or more doses of trial drug included in the analysis.
† 200 mg pretomanid (Pa, PMD) daily, 400 mg moxifloxacin (M) and 1500 mg pyrazinamide (Z) for 6 months (6Pa200MZ) or 4 months (4Pa200MZ); 100 mg pretomanid daily for 4 months in the same combination (4Pa100MZ).
‡ As per site investigator assessment.
DS-TB = drug-susceptible TB; H = isoniazid; R = rifampicin; Z = pyrazinamide; E = ethambutol; M = moxifloxacin; Pa = pretomanid; MDR-TB = multidrug-resistant TB.