26 Änderungen an Fachinfo MabThera 100 mg/10 ml |
- Beobachtung Rituximab HR (95% KI) p-Wert
-Nach 2 Jahren N=513 N= 505
- + Beobachtung Rituximab HR (95% KI) p-Wert
- +Nach 2 Jahren N=513 N= 505
- Beobachtung Rituximab HR (95% KI) p-Wert
-Nach 6 Jahren N= 513 N= 505
- + Beobachtung Rituximab HR (95% KI) p-Wert
- +Nach 6 Jahren N= 513 N= 505
- CHOP R-CHOP p-Wert
- + CHOP R-CHOP p-Wert
- ACR-Response Placebo + MTX Rituximab + MTX 2× 1'000 mg Rituximab + MTX 2× 500 mg
-Studie 1 (WA17042)1 N= 201 RF-positive und -negative Patienten N= 298 RF-positive und -negative Patienten -
- ACR20 36 (18%) 153 (51%)3 -
- ACR50 11 (5%) 80 (27%)3 -
- ACR70 3 (1%) 37 (12%)3 -
-Studie 2 (WA17043)2 N= 143 RF-positive und -negative Patienten N= 185 RF-positive und -negative Patienten N= 123 RF-positive Patienten
- ACR20 45 (31%) 96 (52%)4 68 (55%)4
- ACR50 19 (13%) 61 (33%)4 40 (33%)4
- ACR70 6 (4%) 28 (15%)4 16 (13%)5
-Studie 3 (WA16291)2 N= 40 RF-positive Patienten N= 40 RF-positive Patienten -
- ACR20 15 (38%) 28 (70%)5 -
- ACR50 5 (13%) 17 (43%)5 -
- ACR70 2 (5%) 9 (23%)5 -
- + ACR-Response Placebo + MTX Rituximab + MTX 2× 1'000 mg Rituximab + MTX 2× 500 mg
- +Studie 1 (WA17042)1 N= 201 RF-positive und -negative Patienten N= 298 RF-positive und -negative Patienten -
- + ACR20 36 (18%) 153 (51%)3 -
- + ACR50 11 (5%) 80 (27%)3 -
- + ACR70 3 (1%) 37 (12%)3 -
- +Studie 2 (WA17043)2 N= 143 RF-positive und -negative Patienten N= 185 RF-positive und -negative Patienten N= 123 RF-positive Patienten
- + ACR20 45 (31%) 96 (52%)4 68 (55%)4
- + ACR50 19 (13%) 61 (33%)4 40 (33%)4
- + ACR70 6 (4%) 28 (15%)4 16 (13%)5
- +Studie 3 (WA16291)2 N= 40 RF-positive Patienten N= 40 RF-positive Patienten -
- + ACR20 15 (38%) 28 (70%)5 -
- + ACR50 5 (13%) 17 (43%)5 -
- + ACR70 2 (5%) 9 (23%)5 -
- Placebo + MTX Rituximab + MTX 2× 1’000 mg Rituximab + MTX 2× 500 mg
- + Placebo + MTX Rituximab + MTX 2× 1’000 mg Rituximab + MTX 2× 500 mg
- Plazebo + MTX Rituximab + MTX (2× 1'000 mg)
- + Plazebo + MTX Rituximab + MTX (2× 1'000 mg)
- Studie 1 (WA17042) Studie 2 (WA17043)
- + Studie 1 (WA17042) Studie 2 (WA17043)
-p-Wert* 0,0002
- +p-Wert* 0,0002
-p-Wert* 0,0015
- +p-Wert* 0,0015
-p-Wert* <0,0001
- +p-Wert* <0,0001
-p-Wert* <0,0001
- +p-Wert* <0,0001
- MabThera (N= 99) Cyclophosphamid (N= 98) Behandlungsunterschied (MabThera – Cyclophosphamid)
- + MabThera (N= 99) Cyclophosphamid (N= 98) Behandlungsunterschied (MabThera – Cyclophosphamid)
-Roche Pharma (Schweiz) AG, 4153 Reinach.
- +Roche Pharma (Schweiz) AG, Basel.
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