| Statistically conclusive or suggested result | Inconclusive results | Uncertain results | Safety results | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Extensive stage SCLC (Es-SCLC) - 1st Line (L1) Extensive stage SCLC (Es-SCLC) Extensive stage SCLC (Es-SCLC) - 1st Line (L1) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
versus placebo plus SoC | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| ipilimumab plus SoC vs. placebo plus SoC | 1 | none | inconclusive results for: deaths (OS); DOR; objective responses (ORR); STRAE (any grade); STRAE (grade 3-4); TRAE (any grade); TRAE (grade 3-4); TRAE leading to death (grade 5); TRAE leading to discontinuation (any grade); TRAE leading to discontinuation (grade 3-4); Alopecia TRAE (grade 3-4); Anaemia TRAE (grade 3-4); Colitis TRAE (grade 3-4); Decreased appetite TRAE (grade 3-4); Diarrhoea TRAE (grade 3-4); Endocrine disorders TRAE (grade 3-4) ; Fatigue TRAE (grade 3-4); Gastrointestinal disorders TRAE (grade 3-4) ; Hepatobiliary disorders TRAE (grade 3-4) ; Hyperthyroidism TRAE (grade 3-4); Hypothyroidism TRAE (grade 3-4); Increase AST TRAE (grade 3-4); Increased ALT TRAE (grade 3-4); Nausea TRAE (grade 3-4); Nervous system disorders TRAE (grade 3-4); Peripheral sensory neuropathy TRAE (grade 3-4); Pruritus TRAE (grade 3-4); Rash TRAE (grade 3-4); Skin and subcutaneous tissue disorders TRAE (grade 3-4) ; Thrombocytopenia TRAE (grade 3-4); Vomiting TRAE (grade 3-4) | suggested 15 % decrease in progression or deaths (PFS) but the degree if certainty is unassessable suggested 60 % decrease in Leucopenia TRAE (grade 3-4) but the degree if certainty is unassessable suggested 46 % decrease in Neutropenia TRAE (grade 3-4) but the degree if certainty is unassessable | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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