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This is a multicenter, single-arm, non-interventional study (NIS) with a central registration system and an all-case surveillance system. The observation period is 48 weeks after the start of treatment with Fabhalta.
The observation period will be 48 weeks after the start of treatment with Fabhalta.
For patients in whom treatment with Fabhalta is discontinued within 48 weeks after the start of the treatment, adverse events occurring by the last day of the treatment + 30 days and concomitant drugs will be monitored and recorded in CRFs.
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| Measure | Description | Time Frame |
|---|---|---|
| Occurrence status of infections. | Type, incidence, seriousness, severity, clinical course, factors affecting onset (status of vaccination, name of vaccine administered, complications, baseline white blood cell count/neutrophil count, etc.), and causative organism (including serotype) of adverse events/adverse drug reactions of infections during the treatment period. | 48weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence status of serious hemolysis after discontinuation of Fabhalta. | Number of patients with serious hemolysis after discontinuation of Fabhalta. | 48weeks |
| Occurrence status of adverse events and adverse drug reactions. |
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Inclusion Criteria:
All patients who received Fabhalta.
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Exclusion Criteria:
Patients receiving Fabhalta for an unapproved indication under the Clinical Trials Act or GCP.
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All patients who received Fabhalta.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Handa | Aichi-ken | 475-0817 | Japan | ||
| Novartis Investigative Site |
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Incidence of adverse events and adverse drug reactions during the treatment period.
| 48weeks |
| Incidence of breakthrough hemolysis and change of hemolysis-related markers and status of red blood cell transfusion-free. | Incidence of breakthrough hemolysis per year and change over time in hemolysis-related markers (LDH, Hb, etc.) and status of red blood cell transfusion-free up to Week 48. | 48weeks |
| Nagoya |
| Aichi-ken |
| 453-8511 |
| Japan |
| Novartis Investigative Site | Nagoya | Aichi-ken | 466-8650 | Japan |
| Novartis Investigative Site | Okazaki | Aichi-ken | 444-8553 | Japan |
| Novartis Investigative Site | Toyohashi | Aichi-ken | 441-8570 | Japan |
| Novartis Investigative Site | Toyota | Aichi-ken | 470-0343 | Japan |
| Novartis Investigative Site | Toyota | Aichi-ken | 471-8513 | Japan |
| Novartis Investigative Site | Hachinohe | Aomori | 0391104 | Japan |
| Novartis Investigative Site | Chiba | Chiba | 2608677 | Japan |
| Novartis Investigative Site | Funabashi | Chiba | 273-8556 | Japan |
| Novartis Investigative Site | Kashiwa | Chiba | 277-8567 | Japan |
| Novartis Investigative Site | Narita | Chiba | 286-8523 | Japan |
| Novartis Investigative Site | Matsuyama | Ehime | 790-8524 | Japan |
| Novartis Investigative Site | Fukuoka | Fukuoka | 810-8563 | Japan |
| Novartis Investigative Site | Kurume | Fukuoka | 830-8543 | Japan |
| Novartis Investigative Site | Aizu-Wakamatsu | Fukushima | 9693482 | Japan |
| Novartis Investigative Site | Kohriyama | Fukushima | 963-8022 | Japan |
| Novartis Investigative Site | Maebashi | Gunma | 371-0811 | Japan |
| Novartis Investigative Site | Fukuyama | Hiroshima | 720-0001 | Japan |
| Novartis Investigative Site | Hakodate | Hokkaido | 0410821 | Japan |
| Novartis Investigative Site | Sapporo | Hokkaido | 0030006 | Japan |
| Novartis Investigative Site | Sapporo | Hokkaido | 0640804 | Japan |
| Novartis Investigative Site | Amagasaki | Hyōgo | 660-8511 | Japan |
| Novartis Investigative Site | Ashiya | Hyōgo | 659-0012 | Japan |
| Novartis Investigative Site | Himeji | Hyōgo | 670-8540 | Japan |
| Novartis Investigative Site | Kobe | Hyōgo | 6500047 | Japan |
| Novartis Investigative Site | Kobe | Hyōgo | 651-0072 | Japan |
| Novartis Investigative Site | Nishinomiya | Hyōgo | 662-0918 | Japan |
| Novartis Investigative Site | Nishinomiya | Hyōgo | 6638501 | Japan |
| Novartis Investigative Site | Tsukuba | Ibaraki | 300-2622 | Japan |
| Novartis Investigative Site | Tsukuba | Ibaraki | 3058576 | Japan |
| Novartis Investigative Site | Tsukuba | Ibaraki | Ibaraki | Japan |
| Novartis Investigative Site | Morioka | Iwate | 0200066 | Japan |
| Novartis Investigative Site | Sakaidechō | Kagawa-ken | 762-8550 | Japan |
| Novartis Investigative Site | Kanoya | Kagoshima-ken | 893-0024 | Japan |
| Novartis Investigative Site | Isehara | Kanagawa | 259-1193 | Japan |
| Novartis Investigative Site | Yokohama | Kanagawa | 232-0024 | Japan |
| Novartis Investigative Site | Kumamoto | Kumamoto | 860-8556 | Japan |
| Novartis Investigative Site | Kyoto | Kyoto | 603-8151 | Japan |
| Novartis Investigative Site | Uji | Kyoto | 611-0042 | Japan |
| Novartis Investigative Site | Ōsaki | Miyagi | 989-6183 | Japan |
| Novartis Investigative Site | Miyazaki | Miyazaki | 880-8510 | Japan |
| Novartis Investigative Site | Nobeoka | Miyazaki | 882-0835 | Japan |
| Novartis Investigative Site | Matsumoto | Nagano | 3908621 | Japan |
| Novartis Investigative Site | Nagano | Nagano | 3808582 | Japan |
| Novartis Investigative Site | Suwa | Nagano | 392-8510 | Japan |
| Novartis Investigative Site | Ōmura | Nagasaki | 856-8562 | Japan |
| Novartis Investigative Site | Ikoma | Nara | 630-0293 | Japan |
| Novartis Investigative Site | Nagaoka | Niigata | 940-2085 | Japan |
| Novartis Investigative Site | Beppu | Oita Prefecture | 874-0840 | Japan |
| Novartis Investigative Site | Uruma | Okinawa | 904-2293 | Japan |
| Novartis Investigative Site | Habikino | Osaka | 583-0872 | Japan |
| Novartis Investigative Site | Izumi | Osaka | 594-0071 | Japan |
| Novartis Investigative Site | Moriguchi | Osaka | 570-8540 | Japan |
| Novartis Investigative Site | Suita | Osaka | 565-0871 | Japan |
| Novartis Investigative Site | Saga | Saga-ken | 849-8501 | Japan |
| Novartis Investigative Site | Fukaya | Saitama | 366-0052 | Japan |
| Novartis Investigative Site | Kawagoe | Saitama | 3508550 | Japan |
| Novartis Investigative Site | Tokorozawa | Saitama | 359-0037 | Japan |
| Novartis Investigative Site | Hikone | Shiga | 522-0057 | Japan |
| Novartis Investigative Site | Ōtsu | Shiga | 520-0804 | Japan |
| Novartis Investigative Site | Rittō | Shiga | 520-3046 | Japan |
| Novartis Investigative Site | Iwata | Shizuoka | 438-8550 | Japan |
| Novartis Investigative Site | Shimotsuga Gun | Tochigi | 3210293 | Japan |
| Novartis Investigative Site | Shimotsuke | Tochigi | 329-0498 | Japan |
| Novartis Investigative Site | Utsunomiya | Tochigi | 321-0974 | Japan |
| Novartis Investigative Site | Bunkyo Ku | Tokyo | 1138431 | Japan |
| Novartis Investigative Site | Higashimurayama | Tokyo | 189-8511 | Japan |
| Novartis Investigative Site | Itabashi Ku | Tokyo | 1738606 | Japan |
| Novartis Investigative Site | Itabashi-ku | Tokyo | 1738610 | Japan |
| Novartis Investigative Site | Meguro City | Tokyo | 153-8581 | Japan |
| Novartis Investigative Site | Minato-ku | Tokyo | 105-8471 | Japan |
| Novartis Investigative Site | Nerima City | Tokyo | 113-0033 | Japan |
| Novartis Investigative Site | Nerima City | Tokyo | 179-0072 | Japan |
| Novartis Investigative Site | Ōta-ku | Tokyo | 1438541 | Japan |
| Novartis Investigative Site | Shibuya City | Tokyo | 150-8935 | Japan |
| Novartis Investigative Site | Shinagawa Ku | Tokyo | 1418625 | Japan |
| Novartis Investigative Site | Shinagawa-ku | Tokyo | 1428666 | Japan |
| Novartis Investigative Site | Shinjuku Ku | Tokyo | 160-0023 | Japan |
| Novartis Investigative Site | Toyama | Toyama | 930-0859 | Japan |
| Novartis Investigative Site | Tanabe | Wakayama | 646-8588 | Japan |
| Novartis Investigative Site | Kofu | Yamanashi | 400-8506 | Japan |
| Novartis Investigative Site | Fukushima | 9601295 | Japan |
| Novartis Investigative Site | Ishikawa | 9208641 | Japan |
| Novartis Investigative Site | Kagoshima | 892-0853 | Japan |
| Novartis Investigative Site | Kyoto | 604-8845 | Japan |
| Novartis Investigative Site | Kyoto | 6068507 | Japan |
| Novartis Investigative Site | Niigata | 9518520 | Japan |
| Novartis Investigative Site | Okayama | 7008558 | Japan |
| Novartis Investigative Site | Osaka | 542-0081 | Japan |
| Novartis Investigative Site | Shizuoka | 422-8527 | Japan |
| ID | Term |
|---|---|
| D006457 | Hemoglobinuria, Paroxysmal |
| ID | Term |
|---|---|
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D009190 | Myelodysplastic Syndromes |
| D001855 | Bone Marrow Diseases |
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