3 recommenced at 450 mg BD Resolved Pulmonary Onset day Interrupted Was on embolism 107 nadroparin and Not resolved diclofenac at time. Grade 3 (died due to Rx w tinzaparin. disease prog 7 days Interstitial lung day Withdrawn No significant disease 110 day 113 history or meds. CT showed 3 Not resolved ground-glass opacity, lavage negative for infectious cause. dx as drug-induced Pneumonia 55/M/Asian Onset day Interrupted, Died due to 28 recommenced progressive day 39 at 600 disease day 102. 4 mg BD, decreased to 450 mg BD day 40. CXR showed consolidation recurring day 41, and alectinib was permanently withdrawn. Resolved day 68 Constipation Onset day Interrupted biopsy: 21/215 (due to liver centrilobular ALT increased and enzymes) day hepatic injury, Grade 2/4 AST increased 208 consistent with toxic effect. Withdrawn Specified in day 215 advised PI text:. Resolved day 268 Depression 54/F/Asian Onset day Interrupted History of 10 depression was on Resolved sertraline. Grade 2 Depression worsened with restlessness, crying, insomnia and anxiety.
3 recommenced at 450 mg BD Resolved Pulmonary embolism Onset day 107 Grade 3 Interrupted Not resolved (died due to disease prog 7 days Was on nadroparin and diclofenac at time. Rx w tinzaparin. Interstitial lung disease day 110 3 Withdrawn day 113 Not resolved No significant history or meds. CT showed ground-glass opacity, lavage negative for infectious cause. dx as drug-induced Pneumonia 55/M/Asian Onset day 28 4 Interrupted, recommenced day 39 at 600 mg BD, decreased to 450 mg BD day 40. CXR showed consolidation recurring day 41, and alectinib was permanently withdrawn. Resolved day 68 Died due to progressive disease day 102. Constipation ALT increased and AST increased Onset day 21/215 Grade 2/4 Interrupted (due to liver enzymes) day 208 Withdrawn day 215 Resolved day 268 biopsy: centrilobular hepatic injury, consistent with toxic effect. Specified in advised PI text:. Depression 54/F/Asian Onset day 10 Grade 2 Interrupted Resolved History of depression was on sertraline. Depression worsened with restlessness, crying, insomnia and anxiety.
auspar-alectinib-hydrochloride-171127-cer.docx