Adverse reactions reported in ≥10% of patients in RATIFY1
All Grades* | ||||
Adverse Drug Reactions | RYDAPT + standard chemotherapy (n=229) % |
Placebo + standard chemotherapy (n=226) % |
||
Infections and infestations | ||||
Device-related infection | 24 | 17.3 | ||
Blood and lymphatic system disorders | ||||
Febrile neutropenia | 83.4 | 80.5 | ||
Petechiae | 35.8 | 27 | ||
Lymphopenia† | 16.6 | 18.6 | ||
Immune system disorders | ||||
Hypersensitivity | 15.7 | 14.2 | ||
Psychiatric disorders | ||||
Insomnia | 12.2 | 8 | ||
Nervous system disorders | ||||
Headache | 45.9 | 38.1 | ||
Cardiac disorders | ||||
Hypotension | 14.4 | 15 | ||
Respiratory, thoracic, and mediastinal disorders | ||||
Epistaxis | 27.5 | 23.5 | ||
Laryngeal pain | 11.8 | 9.7 | ||
Dyspnoea | 10.9 | 12.4 | ||
Gastrointestinal disorders | ||||
Nausea | 83.4 | 70.4 | ||
Vomiting | 60.7 | 52.7 | ||
Stomatitis | 21.8 | 14.2 | ||
Abdominal pain upper | 16.6 | 14.6 | ||
Haemorrhoids | 15.3 | 10.6 | ||
Skin and subcutaneous tissue disorders | ||||
Dermatitis exfoliative | 61.6 | 60.6 | ||
Hyperhidrosis | 14.4 | 8 | ||
Musculoskeletal and connective tissue disorders | ||||
Back pain | 21.8 | 15.5 | ||
Arthralgia | 14 | 8 | ||
General disorders and administration-site conditions | ||||
Pyrexia | 34.5 | 35.4 |
Grades 3/4* | ||||
Adverse Drug Reactions | RYDAPT + standard chemotherapy (n=345) % |
Placebo + standard chemotherapy (n=335) % |
||
Infections and infestations | ||||
Device-related infection | 15.7 | 9.9 | ||
Blood and lymphatic system disorders | ||||
Febrile neutropenia | 83.5 | 83.0 | ||
Petechiae | 1.2 | 0.6 | ||
Lymphopenia† | 20 | 22.7 | ||
Immune system disorders | ||||
Hypersensitivity | 0.6 | 1.2 | ||
Psychiatric disorders | ||||
Insomnia | 0 | 0.3 | ||
Nervous system disorders | ||||
Headache | 2.6 | 3 | ||
Cardiac disorders | ||||
Hypotension | 5.5 | 3 | ||
Respiratory, thoracic, and mediastinal disorders | ||||
Epistaxis | 2.6 | 0.6 | ||
Laryngeal pain | 0.6 | 0.9 | ||
Dyspnoea | 5.5 | 3.9 | ||
Gastrointestinal disorders | ||||
Nausea | 5.8 | 10.1 | ||
Vomiting | 2.9 | 4.5 | ||
Stomatitis | 3.5 | 2.7 | ||
Abdominal pain upper | 0 | 0.3 | ||
Haemorrhoids | 1.4 | 0 | ||
Skin and subcutaneous tissue disorders | ||||
Dermatitis exfoliative | 13.6 | 7.5 | ||
Hyperhidrosis | 0 | 0 | ||
Musculoskeletal and connective tissue disorders | ||||
Back pain | 1.4 | 0.6 | ||
Arthralgia | 0.3 | 0.3 | ||
General disorders and administration-site conditions | ||||
Pyrexia | 3.2 | 2.7 |
For trial sites in North America, all grades were collected for 13 prespecified adverse events (AEs). For all other AEs, only grades 3/4 were collected. Therefore, all-grade AEs are summarised only for patients in non–North American trial sites, whereas grades 3/4 are summarised for all trial sites.
Higher frequency with RYDAPT was observed during the maintenance phase.
Rate of discontinuation2
The discontinuation rate due to adverse drug reactions (ADRs) was 3.1% for RYDAPT vs 1.3% for placebo
The most frequent grade 3/4 ADR leading to discontinuation in the RYDAPT arm was exfoliative dermatitis (1.2%)
References: 1. RYDAPT® (midostaurin) 25 mg soft capsules Core Data Sheet, version 1.1. Novartis Pharmaceuticals Corp; 2017. 2. RYDAPT [Summary of Product Characteristics]. Novartis Pharma AG; 2017.