Table 3.
Adverse events observed in prospective investigation group patients
| Event | Prospective investigation group patients who experienced the event (N = 25) |
|---|---|
| Serious adverse eventsa, no. of patients (%) | |
| Total serious adverse events, no. of patients (%) | 11 (44.0) |
| Specific events | |
| Interstitial lung disease | 6 (24.0) |
| Zoster | 1 (4.0) |
| Nocardiosis | 1 (4.0) |
| CMV pneumonitis | 1 (4.0) |
| Pneumocystis jiroveci pneumonia | 1 (4.0) |
| Thrombocytopenia | 1 (4.0) |
| Cataract | 1 (4.0) |
| Acute respiratory failure | 1 (4.0) |
| Pneumomediastinum | 1 (4.0) |
| Ascites | 1 (4.0) |
| Liver cirrhosis | 1 (4.0) |
| Infections and infestations, no. of patients (%) | |
| Any | 19 (76.0) |
| Reported as serious adverse event | 3 (12.0) |
| Exacerbation of interstitial pneumonitisb, no. of patients (%) | |
| Any | 9 (36.0) |
| Reported as serious adverse event | 6 (24.0) |
| Led to treatment discontinuation | 3 (12.0) |
| Resulted in death | 3 (12.0) |
| Deathsc, no. of patients (%) | 4 (16.0)c |
| Adverse events leading to treatment discontinuation, no. of patients (%) | 5 (20.0) |
a
All adverse events that resulted in death; life-threatening illness; persistent or clinically significant disability, incapacity or both; hospitalization or prolongation of hospitalization; a congenital abnormality or birth defect; or cancer.
b
During protocol development, the study team and the Pharmaceuticals and Medical Devices Agency in Japan decided to report all the worsening of respiratory symptoms or findings as adverse events regardless of cause.
c
Includes one patient who died 92 days after the end of the study due to the exacerbation of interstitial pneumonitis that developed during the study (on the 172nd day of the study).